NCT05056597

Brief Summary

The purpose of this study is to investigate areas of the brain responsible for 'liking', 'wanting', and learning in adults with eating disorders using brain imaging techniques, computer tasks, a test meal, and self-report questionnaires and interviews. The investigators will study changes in brain activity using a procedure called functional magnetic resonance imaging (fMRI). This study will include 252 women with an eating disorder (63 AN-restricting type (AN-R), 63 AN-binge eating/purging type (AN-BP), 63 bulimia nervosa (BN)) and 63 healthy controls (HC) aged 18-39. Aim 1: To examine neural differences in 'liking' and 'wanting' in ED relative to HC. Aim 2: To examine differences in instrumental learning for reward and punishment in ED relative to HC. Aim 3: To examine how 'liking' and 'wanting' drive instrumental learning in ED and predict clinical symptoms at baseline and 1 year later. Exploratory Aim: To explore the associations of dopamine function, as measured by neuromelanin MRI (NM-MRI), with ED diagnosis and brain response to 'liking', 'wanting', and learning.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
252

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started May 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress88%
May 2022Jan 2027

First Submitted

Initial submission to the registry

September 9, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 24, 2021

Completed
8 months until next milestone

Study Start

First participant enrolled

May 26, 2022

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

4.6 years

First QC Date

September 9, 2021

Last Update Submit

April 27, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • BOLD response

    Brain activity associated with 'liking', 'wanting', and learning

    1 Year

  • Reward and Punishment Learning

    Task reinforcement learning rate in reward and punishment trials

    1 Year

  • Connectome-based predictive modeling (CPM)

    Functional connectivity maps from task-based fMRI data and clinical data

    1 Year

Study Arms (4)

AN-R

Participants that meet Diagnostic And Statistical Manual Of Mental Disorders (DSM-V) criteria for Anorexia Nervosa restricting subtype.

AN-BP

Participants that meet DSM-V criteria for Anorexia Nervosa binging/purging subtype

BN

Participants that meet DSM-V criteria for Bulimia Nervosa.

Healthy Controls

Participants that do not meet DSM-V criteria for any disorder.

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study will recruit 189 adult women currently ill with ED including anorexia nervosa, restricting type (AN-R, n=63), AN binge eating/purging type (AN-BP, n=63), and bulimia nervosa (BN, n=63) and 63 healthy control (HC) women between the ages of 18 and 39.

You may qualify if:

  • Eating Disorder Group:
  • Between the ages of 18 and 39 years old
  • Meet DSM-V criteria for AN-R, AN-BP, or BN
  • Healthy Control Group:
  • Between the ages of 18 and 39 years old
  • Have maintained 85% to 120% ideal body weight since menarche

You may not qualify if:

  • All Groups:
  • Psychotic illness/other mental illness requiring hospitalization
  • Current dependence on drugs or alcohol defined by DSM IV criteria. Additionally, positive test results for drug use on the day of the scan, apart of marijuana, will result in cancelling or rescheduling the scan because acute use will impact MRI measures.
  • Physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight
  • Neurological disorder, neurodevelopmental disorder, or history of head injury with \>30 min loss of consciousness
  • Any contraindication to undergoing an MRI
  • Primary obsessive compulsive disorder or primary major depressive disorder
  • If taking other psychotropic medication, any change in dosage in the 2 weeks before scanning
  • Meet criteria for the diagnosis of any psychiatric disorder currently
  • Any history of binge eating or purging behaviors, including self-induced vomiting, laxative or diuretic misuse
  • Use of any psychoactive or other medication known to affect mood or concentration in the last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSD Eating Disorders Treatment and Research Program

La Jolla, California, 92121, United States

RECRUITING

MeSH Terms

Conditions

Anorexia NervosaBulimia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Central Study Contacts

Christina Wierenga

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 9, 2021

First Posted

September 24, 2021

Study Start

May 26, 2022

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

April 28, 2026

Record last verified: 2026-04

Locations